6550--VISN 19 Lab Biofire Reagent and Maintenance

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 9 Original Date: 08/30/17 Revision 03 Date: 02/11/2021 DEPARTMENT OF VETERANS AFFAIRS SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5 Acquisition Plan Action ID: 36C259-21-AP-1179 J&A Tracking Number: 2021-09-16T04:35:36 Contracting Activity: Department of Veterans Affairs Network Contracting Office 19 6162 South Willow Drive, Suite 300 Greenwood Village, CO 80111 Organization Activity: VA Cheyenne Medical Center: 2360 east Pershing Blvd., Cheyenne WY 82001 VA Grand Junction Health Care System: 2121 North Avenue, Grand Junction, CO 81501 VA Eastern Oklahoma Health Care System: 1011 Honor Heights Drive, Muskogee, OK 74401 VA Salt Lake City Health Care System: 500 Foothill Drive, Salt Lake City, UT 84148 VA Sheridan Medical Center: 1898 Fort Road, Sheridan, WY 82801 Nature and/or Description of the Action Being Processed: This procurement is for the acquisition of BioFire brand Reagents and Maintenance Service in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. The action to be reviewed and approved is to award a new, five-year, firm-fixed price, single-award, Blanket Purchase Agreement (BPA) to BioFire Diagnostics, LLC. Description of Supplies/Services Required to Meet the Agency s Needs: This procurement is to acquire BioFire reagent kits, verification kits and extended warranties on the Government owned BioFire analyzers. The five-year value is estimated to be $4,700,000.00 and the annual value to be $940,000.00. The period of performance is five-years, beginning 30 September 2021 to 29 September 2026. Statutory Authority Permitting Restricted Competition: FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. - Competition is restricted on this procurement for the reason below: - - - - (X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements - - - - ( ) Unusual and Compelling Urgency - - - - ( ) - Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services - - - - ( ) International Agreement - - - - ( ) Authorized or Required by Statute - - - - ( ) National Security - - - - ( ) Public Interest Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The five facilities listed under #1 above have purchased and therefore own BioFire manufactured analyzers including the FilmArray 2.0 and BioFire TORCH systems. BioFire Diagnostics, LLC provided a letter stating that their reagents and verification kits are proprietary and can only be used on the BioFire analyzers. BioFire Diagnostics, LLC also confirmed that there are no authorized distributors or resellers and only BioFire distributes the reagents and verification kits. BioFire Diagnostics, LLC is the only one responsible source because their equipment, reagents and verification kits are proprietary and must be compatible for usage. For the maintenance, BioFire Diagnostics is the only one responsible source that can provide extended warranties on their manufactured equipment, providing discounts on scheduled maintenance (i.e. preventive maintenance), unscheduled maintenance and repairs on the BioFire FilmArray 2.0 and TORCH systems. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: BioFire Diagnostics, LLC Government representative was contacted to inquire if third party reagents and verification kits can be used on the BioFire analyzers. BioFire Diagnostics, LLC confirmed that only BioFire manufactured reagents and verification kits can be used on the BioFire analyzers. BioFire also confirmed that BioFire is the sole distributor of their reagents and verification kits. This is aligned with industry standards in Pathology and Laboratory testing, wherein vendor manufactured reagents and kits are solely to be used on vendor manufactured analyzers and vice versa. Since the maintenance and reagents are proprietary to BioFire, the Contracting Officer (CO) did not determine separate contracts for the maintenance and reagents. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost to the Government is considered to be fair and reasonable. Even though the acquisition will be an open-market acquisition, BioFire Diagnostics has a Federal Supply Schedule contract on GSA. A couple of the reagents are on the Federal Supply Schedule and it was determined that BioFire provided an unofficial quote with prices below the FSS pricing. Also, a comparison of pricing provided to a single site versus this VISN acquisition showed an increase in the discount percentages for the reagents and verification kits for the VISN. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The CO conducted limited market research due to the proprietary nature of the requirement. The CO searched VetBiz on 04 September 2021, using NAICS code 325413 (In-Vitro Diagnostic Substance Manufacturing) and keyword BioFire reagents . Six (6) SDVOSB and one (1) VOSB returned in the results. All SDVOSB and VOSB vendors showed they can offer general/basic lab reagents but not BioFire brand reagents. The CO searched the internet on 04 September 2021 using the search parameter, BioFire reagents. Only BioFire company websites and BioFire catalogs were shown in the search results. No other third party websites were shown. Acquisition History shows that Eastern Oklahoma VA Medical Center in Muskogee has a Blanket Purchase Agreement with BioFire Diagnostics, LLC to provide BioFire reagents and verification kits for Eastern Oklahoma VA owned FilmArray 2.0 system (manufactured and purchased from BioFire Diagnostics, LLC). VA259-17-A-0082 was awarded 22 September 2017 for a period of base year plus four option years. The BioFire representative confirmed in an email correspondence on 04 August 2021 that a majority of the requirement is on the open-market and not on BioFire s Federal Supply Schedule. Out of the seven reagents and verification kits, only two are on the FSS, and the rest are on the open-market. All of the extended warranties are on the open-market. Based on this information the CO determined this will be a Part 13 versus a Part 8 procurement. Any Other Facts Supporting the Use of Other than Full and Open Competition: No other facts to consider. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City, UT 84108-1214 A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The Agency will survey the market again when this requirement comes up for renewal to see if market conditions have changed. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ Dena Whitney Date Medical Technologist Sheridan VA Medical Center Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer or Designee s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ Ronnie Jones Date Contracting Officer Network Contracting Office 19 One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition. _____________________________ - - - - - - - - - - - - ________________________ Albert Williams - - - - - - - - - Date Director of Contracting Network Contracting Office 19 - - - - - VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition. _____________________________ ________________________ Curtis M. Jordan Date Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)